Works Cited

Clinical Trials: Considerations for Women and Ethnic Minorities

Course #91404 - $30 -

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1. Powe NR, Gary TL. Clinical trials. In: Beech BM, Goodman M (eds). Race and Research: Perspectives on Minority Participation in Health Studies. Washington, DC: American Public Health Association; 2004: 61-78.

2. Gullo K. New survey shows public perception of opportunity to participate in clinical trials has decreased slightly from last year. Harris Interact Healthcare News. 2005;5:1-14.

3. National Institutes of Health. NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. Available at Last accessed April 12, 2022.

4. Rodríguez MD, Rodríguez J, Davis M. Recruitment of first-generation Latinos in a rural community: the essential nature of personal contact. Fam Process. 2006;45(1):87-100.

5. Learn About Clinical Trials. Available at Last accessed April 12, 2022.

6. National Cancer Institute. What Are Clinical Trials? Available at Last accessed April 12, 2022.

7. UCSF Helen Diller Family Comprehensive Cancer Center. What Are Clinical Trials All About? Available Last accessed April 12, 2022.

8. Posavac EJ, Carey RG. Program Evaluation: Methods and Case Studies. 8th ed. New York, NY: Routledge; 2016.

9. Benowitz S. Clinical trial transparency: registries, databases raise questions, stir debate. J Natl Cancer Inst. 2005;97(22):1640-1641.

10. Wadman M. Verdict on clinical trial registries? Good, but must do better. Nat Rev Drug Discov. 2006;5(3):175-176.

11. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Prespect Clin Res. 2010;1(1):6-10.

12. Meldrum ML. A brief history of the randomized controlled trial: from oranges and lemons to the gold standard. Hematol Oncol Clin North Am. 2000;14(4):745-760.

13. Grady C, Bedarida G, Sinaii N, Gregorio MA, Emanuel EJ. Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research. Clinical Trials. 2017;14:526-536.

14. Collier R. Legumes, lemons and streptomycin: a short history of the clinical trial. CMAJ. 2009;180(1):23-24.

15. Sood A, Prasad K, Chhatwani L, et al. Patients' attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84(3):243-247.

16. Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med. 1997;337(20):1436-1440.

17. Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21(5):830-835.

18. Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a grounded theory approach. J Med Ethics. 2007;33(4):234-240.

19. Almeida L, Azevedo B, Nunes T, Vaz-da-Silva M, Soares-da-Silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation. Eur J Clin Pharmacol. 2007;63(11):1085-1094.

20. Jenkins V, Farewell D, Batt L, et al. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103(12):1801-1807.

21. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002;251(2):156-168.

22. Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8(5):616-623.

23. Trauth JM, Musa D, Siminoff L, Jewell IK, Ricci E. Public attitudes regarding willingness to participate in medical research studies.J Health Soc Policy. 2000;12(2):23-43.

24. Goldman DP, Berry SH, McCabe MS, et al. Incremental treatment costs in National Cancer Institute-sponsored clinical trials. JAMA. 2003;289(22):2970-2977.

25. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med. 2002;346(18):1373-1382.

26. Greenberger PE, Knab S. News from the Society for Women's Health Research: subgroup analysis of clinical trials: detecting sex differences. J Womens Health Gend Based Med. 2002;11(1):7-9.

27. Vidaver RM, Lafleur B, Tong C, Bradshaw R, Marts SA. Women subjects in NIH-funded clinical research literature: lack of progress in both representation and analysis by sex. J Womens Health Gend Based Med. 2000;9(5):495-504.

28. Ramasubbu K, Gurm H, Litaker D. Gender bias in clinical trials: do double standards still apply? J Womens Health Gend Based Med. 2001;10(8):757-764.

29. Geller SE, Adams MG, Carnes M. Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials.J Womens Health. 2006;15(10):1123-1131.

30. Blauwet LA, Hayes SN, McManus D, Redberg RF, Walsh MN. Low rate of sex-specific result reporting in cardiovascular trials. Mayo Clin Proc. 2007;82(2):166-170.

31. Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Womens Health (Larchmt). 2011;20(3):315-320.

32. Wendler D, Kington R, Madans J, Van Wye G, Christ-Schmidt H. Minority participation in health research: facts and fiction.PLoS Med. 2006;3(2):153-154.

33. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720-2726.

34. Stone VE, Mauch MY, Steger K, Janas SF, Craven DE. Race, gender, drug use, and participation in AIDs clinical trials: lessons from a municipal hospital cohort. J Gen Intern Med. 1997;12(3):150-157.

35. Stark N, Paskett E, Bell R, et al. Increasing participation of minorities in cancer clinical trials: summary of the "Moving Beyond the Barriers" Conference in North Carolina. J Natl Med Assoc. 2002;94(1):31-39.

36. Mak WW, Law RW, Alvidrez J, Pérez-Stable EJ. Gender and ethnic diversity in NIMH-funded clinical trials: review of a decade of published research. Adm Policy Ment Health. 2007;34(6):497-503.

37. Larson EL, Cohn EG, Meyer DD, Boden-Albala B. Consent administrator training to reduce disparities in research participation.J Nurs Scholarsh. 2009;41(1):95-103.

38. U.S. Census Bureau. Age and Sex Composition: 2010. Available at Last accessed April 12, 2022.

39. U.S. Census Bureau. U.S. Census Bureau Projections Show a Slower Growing, Older, More Diverse Nation a Half Century from Now. Available at Last accessed April 12, 2022.

40. Giacomini M, Baylis F. Excluding women from medical research: reasons and rejoinders. Clinical Researcher. 2003;3(10):12-15.

41. Secundy MG. Ethical issues in research. In: Adams DL (ed). Health Issues for Women of Color: A Cultural Diversity Perspective. Thousand Oaks, CA: Sage Publications; 1995: 228-238.

42. Hussain-Gambles M. Ethnic minority under-representation in clinical trials: whose responsibility is it anyway? J Health Organ Manag. 2003;17(2):138-143.

43. Garber M, Arnold R. Promoting the participation of minorities in research. Am J Bioeth. 2006;6(3):W14-W20.

44. Glanz K, Croyle RT, Chollette VY, Pinn VW. Cancer-related health disparities in women. Am J Public Health. 2003;93(2):292-298.

45. Melloni C, Berger JS, Wang TY, et al. Representation of women in randomized clinical trials of cardiovascular disease prevention. Circ Cardiovasc Qual Outcomes. 2010;3(2):135-142.

46. Hinkle ET. Patient Willingness to Join Clinical Trials Drops Dramatically, New Data Show. Available at Last accessed July 15, 2022.

47. Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1(2):5-22.

48. U.S. Department of Health and Human Services Office of Minority Health. Profile: Black/African Americans. Available at Last accessed April 12, 2022.

49. U.S. Department of Health and Human Services Office of Minority Health. Profile: American Indian/Alaska Native. Available at Last accessed April 12, 2022.

50. U.S. Department of Health and Human Services Office of Minority Health. Profile: Hispanic/Latino Americans. Available at Last accessed April 12, 2022.

51. Vaidya V, Partha G, Karmakar M. Gender differences in utilization of preventive care services in the United States. J Womens Health (Larchmt). 2012;21(2):140-145.

52. Mason SE. Offering African Americans opportunities to participate in clinical trials research: how social workers can help. Health Soc Work. 2005;30(4):296-304.

53. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004;363:263-270.

54. Meinert CL. Redesign of trial under different enrollment mixes. Stat Med. 1999;18(3):241-251.

55. Kenny SC. "I can do the child no good:" Dr. Sims and the enslaved infants of Montgomery, Alabama. Social History of Medicine. 2007;20(2):223-241.

56. Wall LL. The medical ethics of Dr. J. Marion Sims: a fresh look at the historical record. J Med Ethics. 2006;32(6):346-350.

57. Marks L. Human guinea pigs? The history of the early oral contraceptive clinical trials. History and Technology. 1999;15(4):263-288.

58. Gejman PV, Weilbaecher A. History of the eugenic movement. Isr J Psychiatry Relat Sci. 2002;39(4):217-231.

59. Killien M, Bigby JA, Champion V, et al. Involving minority and underrepresented women in clinical trials: the National Centers of Excellence in Women's Health. J Womens Health Gend Based Med. 2000;9(10):1061-1070.

60. Weinstein M. A public culture for guinea pigs: U.S. human research subjects after the Tuskegee Study. Sci Cult. 2001;10(2):195-223.

61. Stevens PE, Pletsch PK. Informed consent and the history of inclusion of women in clinical trials. Health Care Women Int. 2002;23(8):809-819.

62. Van Dyke EM, Gerbert DA, Herman LM, et al. Paradigm shifts in the approach to women's health care. JAAPA. 2006;19(10):50, 52-53, 55.

63. Kahn J. Genes, race, and population: avoiding a collision of categories. Am J Public Health. 2006;96(11):1965-1970.

64. Wells AA, Zebrack B. Psychosocial barriers contributing to the under-representation of racial/ethnic minorities in cancer clinical trials. Soc Work Health Care. 2008;46(2):1-14.

65. Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Intern Med. 2007;167(9):905-912.

66. Woods MN, Harris KJ, Mayo MS, Catley D, Scheibmeir M, Ahluwalia JS. Participation of African Americans in a smoking cessation trial: a quantitative and qualitative study. J Natl Med Assoc. 2002;94(7):609-618.

67. Lin JS, Finlay A, Tu A, Gany FM. Understanding immigrant Chinese Americans' participation in cancer screening and clinical trials. J Community Health. 2005;30(6):451-466.

68. Samsudeen BS, Douglas A, Bhopal RS. Challenges in recruiting South Asians into prevention trials: health professional and community recruiters' perceptions on the PODOSA trial. Public Health. 2011;125(4):201-209.

69. Russell SL, Katz RV, Kressin NR, et al. Beliefs of women's risk as research subjects: a four-city study examining differences by sex and by race/ethnicity. J Womens Health. 2009;18(2):235-243.

70. Hamilton LA, Aliyu MH, Lyons PD, et al. African-American community attitudes and perceptions toward schizophrenia and medical research: an exploratory study. J Natl Med Assoc. 2006;98(1):18-27.

71. Flaskerud JH, Nyamathi AM. Attaining gender and ethnic diversity in health intervention resesearch: cultural responsiveness versus resource provision. ANS Adv Nurs Sci. 2000;22(4):1-15.

72. Hochhauser M. Informed consent and patient's rights documents: a right, a rite, or a rewrite? Ethics Behav. 1999;9(1):1-20.

73. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772-1777.

74. Durant RW, Legedza AT, Marcantonio ER, Freeman MB, Landon BE. Different types of distrust in clinical research among whites and African Americans. J Natl Med Assoc. 2011;103(2):123-130.

75. Bates BR, Harris TM. The Tuskegee study of untreated syphilis and public perceptions of biomedical research: a focus group study.J Natl Med Assoc. 2004;96(8):1051-1064.

76. Mays VM, Coles CN, Cochran SD. Is there a legacy of the U.S. Public Health Syphilis Study at Tuskegee in HIV/AIDS-related beliefs among heterosexual African-Americans and Latinos? Ethics Behav. 2012;22(6):461-471.

77. Gilley BJ, Keesee M. Linking "white oppression" and HIV/AIDS in American Indian etiology: conspiracy beliefs among MSMs and their peers. Am Indian Alsk Native Ment Health Res. 2007;14(1):44-62.

78. Bogart LM, Thorburn S. Are HIV/AIDS conspiracy beliefs a barrier to HIV prevention among African Americans? J Acquir Immune Defic Syndr. 2005;38(2):213-218.

79. Moutsiakis DL, Chin NP. Why Blacks do not take part in HIV vaccine trials. J Natl Med Assoc. 2007;99(3):254-257.

80. Knerr S, Wayman D, Bonham VL. Inclusion of racial and ethnic minorities in genetic research: advance the spirit by changing the rules? J Law Med Ethics. 2011;39(3):502-512.

81. Fisher JA, Kalbaugh CA. Challenging assumptions about minority participation in US clinical research. Am J Public Health. 2011;101(12):2217-2222.

82. Johnson VA, Edwards KA, Sherman SL, et al. Decisions to participate in fragile X and other genomics-related research: Native American and African. J Cult Divers. 2009;16(3):127-135.

83. Saldov M, Kakai H, McLaughlin L, Thomas A. Cultural barriers in oncology: issues in obtaining medical informed consent from Japanese-American elders in Hawaii. J Cross Cult Gerontol. 1998;13(3):265-279.

84. Rooney LK, Bhopal R, Halani L, et al. Promoting recruitment of minority ethnic groups into research: qualitative study exploring the views of South Asian people with asthma. J Public Health (Oxf). 2011;33(4):604-615.

85. Hsiung YY, Ferrans CE. Recognizing Chinese Americans' cultural needs in making end-of-life treatment decisions. J Hosp Palliat Nurs. 2007;9(3):132-140.

86. Palafox NA, Buenconsejo-Lum L, Riklon S, Waitzfelder B. Improving health outcomes in diverse populations: competency in cross-cultural research with indigenous Pacific Islander populations. Ethn Health. 2002;7(4):279-285.

87. Gwadz MV, Leonard NR, Nakagawa A, et al. Gender differences in attitudes toward AIDS clinical trials among urban HIV-infected individuals from racial and ethnic minority backgrounds. AIDS Care. 2006;18(7):786-794.

88. Han H, Kang J, Kim KB, Ryu JP, Kim MT. Barriers to and strategies for recruiting Korean Americans for community-partnered health promotion research. J Immigr Minor Health. 2007;9(2):137-146.

89. Stoddart ML, Jarvis B, Blake B, Fabsitz RR, Howard BV, Lee ET, Welty TK. Recruitment of American Indians in epidemiologic research: the strong heart study. Am Indian Alsk Native Ment Health Res. 2000;9(3):20-37.

90. Schmidt CW. Indi-gene-ous conflict. Environ Health Perspect. 2001;109(5):A216-A219.

91. Brown R, Bylund CL, Siminoff LA, Slovin SF. Seeking informed consent to phase I cancer clinical trials: identifying oncologists' communication strategies. Psychooncology. 2011;20(4):361-368.

92. Zaller N, Nelson KE, Ness P, Wen G, Bai X, Shan H. Knowledge, attitude and practice survey regarding blood donation in a Northwestern Chinese city. Transfus Med. 2005;15(4):277-286.

93. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Government Printing Office; 1979. Available at Last accessed April 12, 2022.

94. Helmreich RJ, Hundley V, Norman A, Ighedosa J, Chow E. Research in pregnant women: the challenges of informed consent.Nurs Womens Health. 2007;11(6):576-585.

95. Meddings F, Haith-Cooper M. Culture and communication in ethically appropriate care. Nurs Ethics. 2008;15(1):52-61.

96. Hanssen I. An intercultural nursing perspective on autonomy. Nurs Ethics. 2004;11(1):28-41.

97. Mehlman MJ, Berg JW. Human subjects protections in biomedical enhancement research: assessing risk and human benefit and obtaining informed consent. J Law Med Ethics. 2008;36(3):546-549.

98. Schonfeld TL, Amoura NJ, Stoner JA, Gordon BG. Women and contraception in research: a pilot study. J Womens Health. 2009;18(4):507-512.

99. Resnik DB. Randomized controlled trials in environmental health research: ethical issues. J Environ Health. 2008;70(6):28-30.

100. Maxwell AE, Bastani R, Vida P, Warda US. Strategies to recruit and retain older Filipino-American immigrants for a cancer screening study. J Community Health. 2005;30(3):167-179.

101. Larson EL, Ferng YH, Wong-McLoughlin J, Wang S. Retention and protocol adherence of Hispanic volunteers in a longitudinal trial. Am J Health Behav. 2009;33(4):435-444.

102. Ramos-Gomez F, Chung LH, Gonzalez Beristain R, et al. Recruiting and retaining pregnant women from a community health center at the US-Mexico border for the Mothers and Youth Access clinical trial. Clin Trials. 2008;5(4):336-346.

103. Olsen SJ, Malvern KT, May BJ, Jenkins IL, Griffin CA. Partnership with an African American sorority to enhance participation in cancer genetics research. Community Genet. 2008;11(4):201-207.

104. James RD, Yu JH, Henrikson NB, Bowen DJ, Fullerton SM. Strategies and stakeholders: minority recruitment in cancer genetics research. Community Genet. 2008;11(4):241-249.

105. Zhu K, Hunter S, Bernard LJ, Payne-Wilks K, Roland CL, Levine RS. Recruiting elderly African-American women in cancer prevention and control studies: a multifaceted approach and its effectiveness. J Natl Med Assoc. 2000;92(4):169-175.

106. Ejiogu N, Norbeck JH, Mason MA, Cromwell BC, Zonderman AB, Evans MK. Recruitment and retention strategies for minority or poor clinical research participants: lessons from the Healthy Aging in Neighborhoods of Diversity across the Life Span study. Gerontologist. 2011;51 Suppl 1:S33-S45.

107. King WD, Defreitas D, Smith K, et al. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study. AIDS Patient Care STDs. 2007;21(8):551-563.

108. Yick AG, Berthold SM. Conducting research on violence in Asian American communities: methodological issues. Violence Vict. 2005;20(6):661-677.

109. Bhopal R. Race and ethnicity: responsible use from epidemiological and public health perspectives. J Law Med Ethics. 2006;34(3):500-507.

110. Roberts DE. Legal constraints on the use of race in biomedical research: toward a social justice framework. J Law Med Ethics. 2006;34(3):526-534.

111. Wood SF. Tracking inclusion of women in clinical trials. J Womens Health. 2010;18(3):301-302.

112. Green L. Explaining the role of the nurse in clinical trials. Nurs Stand. 2011;25(22):35-39.

113. Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in Ann Intern Med. 2010;153(3):158-166.

114. Collier R. Clinical trial registries becoming a reality, but long-term effects remain uncertain. CMAJ. 2009;180(10):1007-1008.

115. Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010;1(1):6-10.

116. Cimons M. CDC Says It Erred in Measles Study. Available at Last accessed April 12, 2022.

117. McCarthy CR. Historical background of clinical trials involving women and minorities. Acad Med. 1994;69(9):695-698.

118. Joshi V, Kulkarni AA. Public awareness of clinical trials: a qualitative pilot study in Pune. Perspect Clin Res. 2012;3(4):125-132.

119. Foulkes MA. After inclusion, information and inference: reporting on clinical trials results after 15 years of monitoring inclusion of women. J Womens Health. 2011;20(6):829-836.

120. Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J Womens Health. 2011;20(3):315-320.

121. Kaneshiro B, Geling O, Gellert K, Millar L. The challenges of collecting data on race and ethnicity in a diverse, multiethnic state. Hawaii Med J. 2011;70(8):168-171.

122. Trends, Charts, and Maps. Available at Last accessed April 12, 2022.

123. Blauwet LA. Sex and race/ethnicity reporting in clinical trials: a necessity, not an option. J Womens Health. 2011;20(3):313-314.

124. Berlin JA, Ellenberg SS. Commentary: inclusion of women in clinical trials. BMC Med. 2009;7:56.

125. Rivera-Goba MV, Dominguez DC, Stoll P, et al. Exploring decision-making of HIV-infected Hispanics and African Americans participating in clinical trials. J Assoc Nurses AIDS Care. 2011;22(4):295-306.

126. Azétsop J, Rennie S. Principlism, medical individualism, and health promotion in resource-poor countries: can autonomy based bioethics promote social justice and population health? Philos Ethics Humanit Med. 2010;5:1.

127. Kass NE, Chaisson L, Taylor HA, Lohse J. Length and complexity of U.S. and international HIV consent forms from federal HIV Network Trials. J Gen Intern Med. 2011;26(11):1324-1328.

128. Green BL, Li L, Morris JF, et al. Detailed knowledge of the Tuskegee Syphilis Study: who knows what? A framework for health promotion strategies. Health Educ Behav. 2011;38(6):629-636.

129. Ross MW, Essien EJ, Torres I. Conspiracy beliefs about the origins of HIV/AIDS in four racial/ethnic groups. J Acquir Immune Defic Syndr. 2006;41(3):342-344.

130. Symonds RP, Lord K, Mitchell AJ, Raghavan D. Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 2012;107(7):1017-1021.

131. Bishop FL, Adams AEM, Kaptchuk TJ, Lewith GT. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trials participants are told about placebos. PLoS One. 2012;7(6):1-7.

132. Germino BB, Mishel MH, Alexander GR, et al. Engaging African American breast cancer survivors in an intervention trial: culture, responsiveness and community. J Cancer Surviv. 2011;5(1):82-91.

133. Las Nueces D, Hacker K, DiGirolamo A, Hicks LS. A systematic review of community-based participatory research to enhance clinical trials in racial and ethnic minority groups. Health Serv Res. 2012;47(3 Part 2):1363-1386.

134. Falcon R, Bridge DA, Currier J, et al. Recruitment and retention of diverse populations in antiretroviral clinical trials: practical applications from the gender, race, and clinical experience study. J Womens Health. 2011;20(7):1043-1050.

135. Okuyemi K, Cox L, Nollen N, et al. Baseline characteristics and recruitment strategies in a randomized clinical trial of African-American light smokers. Am J Health Promot. 2007;21:183-191.

136. Sadler GR, Gonzalez J, Mumman M, et al. Adapting a program to inform African American and Hispanic American women about cancer clinical trials. J Cancer Educ. 2010;25(2):142-145.

137. Nicholson L, Schwirian PM, Klein EG, et al. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2012;32(3):353-362.

138. Phillips AK, Fischer BA, Baxter RJ, et al. Recruiting Latina families in a study of infant iron deficiency: a description of barriers, study adjustments and review of the literature. WMJ. 2011;110(1):26-31.

139. The Center for Information and Study on Clinical Research Participation. Charts and Statistics: Useful Information about Clinical Research Before Participating in a Trial. Available at Last accessed April 12, 2022.

140. Sharma NS. Patient centric approach for clinical trials: current trend and new opportunities. Perspect Clin Res. 2015;6(3):134-138.

141. World Medical Association. WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at Last accessed April 12, 2022.

142. Mazure CM, Jones DP. Twenty years and still counting: including women as participants and studying sex and gender in biomedical research. BMC Women's Health. 2015;15:1-16.

143. Wechsler J. Clamor grows to expand trial participation of women and minorities. Appl Clin Trials. 2014;23(8/9):10.

144. Ramers-Verhoeven CW, Perrone F, Oliver K. Exploratory research into cancer patients' attitudes to clinical trials. E Cancer Medical Science. 2014;8:413-446.

145. Bloch F, Charasz N. Attitudes of older adults to their participation in clinical trials: a pilot study. Drugs Aging. 2014;31(5):373-377.

146. Kwiatkowski K, Coe K, Bailar JC, Swanson GM. Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved? Cancer. 2013;119(16):2956-2963.

147. Chen MS Jr, Lara PN, Dang JH, Paterniti DA, Kelly K. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual. Renewing the case for enhancing minority participation in cancer clinical trials. Cancer. 2014;120(Suppl 7):1091-1096.

148. National Institutes of Health. NIH Clinical Research Trials and You: Basics. Available at Last accessed July 15, 2022.

149. Ruiz-Casares M. Research ethics in global mental health: advancing culturally responsive mental health research. Transcult Psychiatry. 2014;51(6):790-805.

150. Rush University Medical Center. How Gender Affects Health: When It Comes to Health, Women and Men Aren't Equal. Available at Last accessed April 12, 2022.

151. Salganicoff A, Ranjii U, Beamesderfer A, Kurani N. Women and Health Care in the Early Years of the ACA: Key Findings from the 2013 Kaiser Women's Health Survey. Available at Last accessed April 12, 2022.

152. Manne S, Kashy D, Albrecht T, et al. Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers. Eur J Cancer Care. 2015;24(1):28-38.

153. Livaudais-Toman J, Burke NJ, Napoles A, Kaplan CP. Health literate organizations: are clinical trial sites equipped to recruit minority and limited health literacy patients? J Health Dispar Res Pract. 2014;7(4):1-13.

154. Ford ME, Siminoff LA, Pickelsimer E, Mainous AG. Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Health Soc Work. 2013;38(1):29-38.

155. Sprague D, Russo J, LaVallie DL, Buchwald D. Barriers to cancer clinical trial participation among American Indian and Alaska Native tribal college students. J Rural Health. 2013;29(1):55-60.

156. Heller C, Balls-Berry JE, Nery JD, et al. Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review. Contemp Clin Trials. 2014;39(2):169-182.

157. Eggly S, Barton E, Winckles A, et al. A disparity of words: racial differences in oncologist-patient communication about clinical trials. Health Expect. 2015;18(5):1316-1326.

158. Frew PM, Omer SB, Parker K, et al. Delivering a "dose of hope:" a faith-based program to increase older African Americans' participation in clinical trials. JMIR Res Protoc. 2015;4(2):e64.

159. Ma GX, Seals B, Tan Y, et al. Increasing Asian American participation in clinical trials by addressing community concerns.Clin Trials. 2014;11(3):328-335.

160. Anderson A, Borfitz D, Getz K. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Netw Open. 2018;1(6):e182969.

161. Vitale C, Fini M, Spoletini I, Lainscak M, Seferovic P, Rosano GM. Under-representation of elderly and women in clinical trials. Int J Cardiol. 2017;232:216-221.

162. Nellhaus EM, Davies TH. Evolution of clinical trials throughout history. Marshall Journal of Medicine. 2017;3(1):9.

163. Bothwell LE, Podolsky SH. History of clinical trials: the emergence of the randomized, controlled trial. N Engl J Med. 2016;375(6):501-504.

164. History, Policies, and Laws. Available at Last accessed April 12, 2022.

165. Burchard EG, Oh SS, Foreman MG, Celedon JC. Moving toward true inclusion of racial/ethnic minorities in federally funded studies. Am J Respir Crit Care Med. 2015;191(5):514-521.

166. Fisher JA, McManus L, Wood MM, et al. Healthy volunteers' perceptions of the benefits of their participation in phase I clinical trials. J Empir Res Hum Res Ethics. 2018;13(5):494-510.

167. Igwe E, Woodburn J, Davolos J, et al. Patient perceptions and willingness to participate in clinical trials. Gynecol Oncol. 2016;142(3):520-524.

168. Cartmell KB, Bonilha HS, Matson T, et al. Patient participation in cancer clinical trials: a pilot test of lay navigation. Contemp Clin Trials Commun. 2016;3:86e93.

169. Willison DJ, Richards DP, Orth A, Harris H, Marlin S. Survey of awareness and perceptions of Canadians on the benefits and risks of clinical trials. Ther Innov Regul Sci. 2018; [Epub ahead of print].

170. Research!America. Public Perceptions of Clinical Trials. Available at Last accessed April 12, 2022.

171. Hoff C. Taking on Gender Bias in Clinical Trials. Available at Last accessed April 12, 2022.

172. Duma N, Aguilera JV, Paludo J, et al. Representation of minorities and women in oncology clinical trials: review of the past 14 years. J Oncol Pract. 2018;14(1):e1-e10.

173. Geller SE, Koch AR, Roesch P, Filut A, Hallgren E, Carnes M. The more things change, the more they stay the same: a study to evaluate compliance with inclusion and assessment of women and minorities in randomized controlled trials. Acad Med. 2018;93(4):630-635.

174. Michaels TI, Purdon J, Collins A, Williams MT. Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature. BMC Psychiatry. 2018;18:245.

175. Martinez LS, Freeman ER, Winkfield KM. Perceptions of cancer care and clinical trials in the black community: implications for care coordination between oncology and primary care teams. Oncologist. 2017;22(9):1094-1101.

176. Herzog-LeBoeuf C, Willenberg KM. The history of clinical trials research: implications for oncology nurses. Seminars in Oncology Nursing. 2020;36(2).

177. Podolsky SH. Antibiotics and the social history of the controlled clinical trial: 1950-1970. Journal of the History of Medicine and Allied Sciences. 2010;65(3):327.

178. Centers for Disease Control and Prevention. CDC Health Disparities and Inequalities Report. Available at Last accessed April 12, 2022.

179. Coakley M, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health (Larchmt). 2012;21(7):713-716.

180. Lyerly AD. Should Pregnant Women be Included in Clinical Trials? Available at Last accessed July 15, 2022.

181. Liu KA, Dipietro NA. Women's involvement in clinical trials: historical perspective and future implications. Pharm Pract (Granada). 2016;14(1):1-9.

182. National Institute on Drug Abuse. The Importance of Including Women in Research. Available at Last accessed April 12, 2022.

183. Geana M, Erba J, Krebill H, et al. Searching for cures: inner-city and rural patients' awareness and perceptions of cancer clinical trials. Contemp Clin Trials Commun. 2017;5:72-79.

184. Kim S, Tanner A, Friedman DB, Foster C, Bergeron C. Barriers to clinical trial participation: comparing perceptions and knowledge of African American and white South Carolinians. J Health Commun. 2015;20(7):816-826.

185. Myles S, Tocci C, Falk M, et al. (2018). A multicenter investigation of factors influencing women's participation in clinical trials.J Womens Health (Larchmt). 2018;27(3):258-270.

186. Salman A, Nguyen C, Lee Y, Cooksey-James T. A review of barriers to minorities' participation in cancer clinical trials: implications for future cancer research. J Immigr Minor Health. 2016;18(2):447-453.

187. Tanner A, Kim SH, Friedman DB, Foster C, Bergeron CD. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and African American communities. J Health Commun. 2015;20(1):88-96.

188. Masood Y, Bower P, Waheed MW, Brown G, Waheed W. Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: a systematic review. Contemp Clin Trials. 2019;78:1-10.

189. Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018;23(10):1242-1249.

190. Price A, Liew SM, Kirkpatrick J, Price J, Lopreto T, Nelken Y. Mind the gap in clinical trials: a participatory action analysis with citizen collaborators. J Eval Clin Pract. 2017;23(1):178-184.

191. Hammer MJ, Eckardt P, Barton-Burke M. Informed consent: a clinical trials perspective. Oncol Nurs Forum. 2016;43(6):694-696.

192. Regnante JM, Richie NA, Fashoyin-Aje L, et al. US cancer centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials. Journal of Oncology Practice. 2019;15(4):e289-e299.

193. Singler L, McAdams P, Uhlenbrauck G, Jernigan K, Schulman J. Models of engagement: patients as partners in clinical research: exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs. Applied Clinical Trials. 2018;27(6):28-31.

194. Winter SS, Page-Reeves JM, Page KA, et al. Inclusion of special populations in clinical research: important considerations and guidelines. J Clin Transl Res. 2018;4(1):56-69.

195. Smith A, Agar M, Delaney G, et al. Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers. Asia Pac J Clin Oncol. 2018;14(1):52-60.

196. Flocke SA, Antognoli E, Daly BJ, et al. The role of oncology nurses in discussing clinical trials. Oncol Nurs Forum. 2017;44(5): 547-553.

197. Peterson EB, Chou WS, Falisi A, Ferrer R, Mollica MA. The role of medical social workers in cancer clinical trial teams: a group case study of multidisciplinary perspectives. Soc Work Health Care. 2018;57(8):688-704.

198. Rodríguez-Torres E, González-Pérez MM, Díaz-Pérez C. Barriers and facilitators to the participation of subjects in clinical trials: an overview of reviews. Contemp Clin Trials Commun. 2021;23:100829.

199. History, Policies, and Laws. Available at Last accessed July 15, 2022.

200. PMLiVE. Names Erased from History: A Dive into Black History of Clinical Research. Available at Last accessed July 15, 2022.

201. Perlstein OC. COVID research inequalities: highlighting the need for increased minority participation in clinical trials. Seton Hall Law Review. 2021;52(2):545.

202. Jiang S, Hong A. Clinical trial participation in America: the roles of eHealth engagement and patient-provider communication. Digital Health. 2021;7.

203. Abdelhafiz AS, ElHafeez SA, Khalil MA, et al. Factors influencing participation in COVID-19 clinical trials: a multi-national study. Front Med (Lausanne). 2021;8:608959.

204. Lee E, Wen P. Gender and sex disparity in cancer trials. ESMO Open. 2020;5(Suppl4):e000773.

205. Gaudino M, Di Mauro M, Fremes SE, Di Franco A. Representation of women in randomized trials in cardiac surgery: a meta-analysis. Journal of the American Heart Association. 2021;10:e020513.

206. Clemens KK, Woodward M, Neal B, Zinman B. Sex disparities in cardiovascular outcome trials of populations with diabetes: a systematic review and meta-analysis. Diabetes Care. 2020;43(5):1157-1163.

207. Flores LE, Frontera WR, Andrasik MP, et al. Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA Network Open. 2020;4(2):e2037640.

208. Artiga S, Kates J, Michaud J, Hill L. Racial Diversity Within COVID-19 Vaccine Clinical Trials: Key Questions and Answers. Available at Last accessed July 15, 2022.

209. Habr D, Ferdinand R. Addressing racial/ethnic disparities in cancer clinical trials: everyone has a role to play. Cancer. 2021;127(18):3282-3289.

210. U.S. Census Bureau. Women's History Month: March 2022. Available at Last accessed July 15, 2022.

211. Office of Minority Health. Heart Disease and African Americans. Available at Last accessed July 15, 2022.

212. GlobalData Healthcare. Clinical Trials and the Ongoing Battle with Racial Bias. Available at Last accessed July 15, 2022.

213. Kalseth J, Halvorsen T. Health and care service utilisation and cost over the life-span: a descriptive analysis of population data. BMC Health Services Research. 2020;20:435.

214. Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biological Sex Differences. 2020;11(32).

215. Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities; Board on Population Health and Public Health Practice; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine. Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop. Available at Last accessed July 15, 2022.

216. Swaby J, Kaninjing E, Ogunsanya M. African American participation in cancer clinical trials. E-Cancer Medical Science. 2021;15(1264-1315):1-13.

217. Cunningham-Erves J, Barajas C, Mayo-Gamble TL, et. al. Formative research to design a culturally-appropriate cancer clinical trial education program to increase participation of African American and Latino communities. BMC Public Health. 2020;20(1):840.

218. Granda-Cameron C, McLean Florence Y, Whitfield-Harris L, Kates J, Lenzo J. Perceptions of clinical trial participation in African American cancer survivors and caregivers. Oncology Nursing Forum. 2022;49(2):113-124.

219. DaSol AH, Lee A, Song JM, Han H-R. Recruitment and retention strategies among racial and ethnic minorities in web-based intervention trials: retrospective qualitative analysis. Journal of Medical Internet Research. 2021;23(7):e23959.

220. National Institutes of Health Clinical Center. Patient Recruitment Ethics in Clinical Research: Ethical Guidelines. Available at Last accessed July 15, 2022.

221. Ali, J, Davis, AF, Burgess, DJ, et al. Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems. Learn Health Sys. 2022;6(2):e10291.

222. Clark LT, Watkins L, Piña IL, et al. Increasing diversity in clinical trials: overcoming critical barriers. Curr Probl Cardiol. 2019;44(5):148-172.

223. Andrasik MP, Broder GB, Wallace SE, et al. Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment. PLoS ONE. 2021;16(10):1-13.

224. Vuong I, Wright J, Nolan MB, et al. Overcoming barriers: Evidence-based strategies to increase enrollment of underrepresented populations in cancer therapeutic clinical trial: a narrative review. Journal of Cancer Education. 2020;35(5):841-849.

225. Halkoaho A, Pietilä AM, Ebbesen M, Karki S, Kangasniemi M. Cultural aspects related to informed consent in health research: a systematic review. Nursing Ethics. 2016;23(6):698-712.

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